Self-Management Training Among Individuals With TBI
Chronic Disease Self-Management Among Individuals With TBI
Traumatic brain injury (TBI) can have long-term and chronic effects on an individual's physical, social, and emotional health, impacting quality of life and the ability to engage in meaningful life roles. Despite the potential for long-term effects, much of the care for individuals with TBI is front-loaded in the weeks to months post-injury. Self-management and self-management training are key components of long-term care for many chronic health conditions, but they are not standard parts of care for individuals with TBI.
In this study the investigators will address two objectives: 1) identify self-management priorities from the perspectives of individuals with chronic TBI, families, and health care providers and 2) pilot test an existing virtual community-based self-management training program (the Chronic Disease Self-Management Program (CDMSP)), to a) evaluate changes in quality of life, self-management self-efficacy, and other patient-reported outcomes before and after participating in the training, and b) identify barriers and facilitators to participating in community-based self-management training.
調査の概要
状態
条件
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Emily Evans, PT, PhD
- 電話番号：(617) 353 7493
- メール：eaevans@bu.edu
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Aged ≥18 years at time of first TBI
- At least one year since the most recent TBI
- Received care at BMC's Concussion/TBI program for a TBI or concussion
- At least partially involved in Self-care
- Able to provide consent
- Able to speak and understand English
- Available for study duration.
Exclusion Criteria:
• Aged <18 at the time of their first TBI
- Severe mental, cognitive, social, or emotional difficulties due to another neurologic, developmental, psychological condition, or active substance use disorder
- Participating in another interventional clinical trial
- Planned major surgery in the next 4 months.
- Pregnancy (self-report).
- Suspected or known drugs or alcohol abuse
- Endorses suicidal ideation
- All individuals with reduced decision-making capacity, an assigned LAR, or conservator.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Self-management training
Individuals enrolled in this arm will participate in a community-based self management training program
|
Individuals will participate in a 6-week group training course run by a community-based organization that provides training in self-management skills for individuals with chronic health conditions.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
PROMIS Self-Efficacy to Manage Chronic Disease Scale
時間枠：baseline, after the intervention on average 6 weeks
|
A patient reported outcome measure that assesses self-efficacy to managing chronic disease across 5 domains: Managing: Symptoms, Social Interactions, Medications, Emotions, and Daily Activities
|
baseline, after the intervention on average 6 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Quality of Life After Brain Injury
時間枠：baseline, after the intervention on average 6 weeks
|
This tool was developed to assess quality of life among individuals with traumatic brain injury
|
baseline, after the intervention on average 6 weeks
|
協力者と研究者
捜査官
- 主任研究者：Emily Evans, PT, PhD、Boston University Charles River Campus
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。